Incontinence treatment device including non-porous cuff and extending members

ABSTRACT

An incontinence treatment device includes a non-porous support and an extending member. The non-porous support has a first end portion provided with a slot and a second end portion. The second end portion is insertable through the slot to form a cuff that is configured for placement around a urethra of a user. The extending member is attached to the support at a junction located between the first end portion and the second end portion. Tension applied to the second end portion is adapted to draw the junction toward the slot to tighten the cuff and thus provide the user with a continent state. Tension applied to the extending member is adapted to draw the juncture away from the slot and expand the cuff and thus allow the user to urinate.

BACKGROUND

Devices for treating urinary incontinence include slings, supports,artificial urinary sphincters and other devices that are implanted in auser to support and/or coapt the urethra.

A sling is a device that is surgically implanted to support the urethraand inhibit urine from undesirably leaking from the urethra. Slings aretypically fabricated from mesh and are implanted through one or moreincisions. The sling is secured to supporting tissue(s) and the tissueeventually grows through the mesh to support the urethra. The surgeonwill peri-operatively determine and achieve the appropriate level oftension in the sling relative to the urethra that will post-operativelyprovide the user with a continent state.

An artificial urinary sphincter is generally provided as an inflatablering or “donut” that is surgically implanted around the urethra. Somepeople become incontinent after having a portion or all of the prostategland removed, which can result in a loss of some or all of the functionof the prostatic urinary sphincter. An artificial urinary sphincterimplanted around the compromised prostatic urinary sphincter can providethe patient with improved control of urinary function.

Improved incontinence treatment devices would be welcomed by both thepatient and the surgical staff.

SUMMARY

One aspect provides an incontinence treatment device including anon-porous support and an extending member. The non-porous support has afirst end portion provided with a slot and a second end portion. Thesecond end portion is insertable through the slot to form a cuff that isconfigured for placement around a urethra of a user. The extendingmember is attached to the support at a junction located between thefirst end portion and the second end portion. Tension applied to thesecond end portion is adapted to draw the junction toward the slot totighten the cuff and thus provide the user with a continent state.Tension applied to the extending member is adapted to draw the junctureaway from the slot and expand the cuff and thus allow the user tourinate.

One aspect provides an incontinence treatment device including anon-porous sheet and an extending member attached to the non-poroussheet. The non-porous sheet has a first side spaced apart from a secondside by a sheet width, a first end portion having a width that isapproximately equal to the sheet width with a slot formed in the firstend portion, and a second end portion that tapers to a tapered widththat is less than the sheet width. The extending member has a first endthat is attached to the sheet at a junction located between the firstend portion and the second end portion. The extending member includes asecond end that has a width that is less than the sheet width. Thetapered width of the second end portion of the sheet is insertablethrough the slot in the first end portion to form a cuff from thenon-porous sheet that is sized for placement around a human urethra. Theslot has a slot width that prevents the junction from passing throughthe slot.

One aspect provides a method of treating urinary incontinence thatincludes making an incision and exposing tissue of a urethra, andinserting a non-porous sheet into the incision and forming a cuff aroundthe urethra with the non-porous sheet by directing a first end of thenon-porous sheet through a slot formed in a second end of the non-poroussheet. The method further includes directing an extending member that isattached to the non-porous sheet to a location outside of the pelvis.The method additionally includes configuring the cuff to tighten aroundthe urethra when pulling on the first end of the non-porous sheet, andconfiguring the cuff to be loosely positioned around the urethra whenpulling on the extending member.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1 is a top view of one embodiment of an incontinence treatmentdevice.

FIG. 2 is a perspective view of the incontinence treatment deviceillustrated in FIG. 1 as assembled to provide a cuff.

FIG. 3 is a top view of the incontinence treatment device illustrated inFIG. 2.

FIG. 4A is a top view and FIG. 4B is an expanded view of theincontinence treatment device illustrated in FIG. 3 with tension appliedto tighten the cuff of the device.

FIG. 4C is a top view of the incontinence treatment device illustratedin FIG. 4A with tension applied to a second extending member to loosenthe cuff of the device.

FIG. 5 is a schematic view of one embodiment of an incontinencetreatment device with a cuff implanted around the urethra and extendingmembers directed behind a pubic symphysis and through a wall of anabdomen.

FIG. 6 is a schematic view of one embodiment of an incontinencetreatment device with a cuff implanted around the urethra and extendingmembers directed through obturator foramina and through a groin of auser.

FIG. 7A is a schematic view of one embodiment of an incontinencetreatment device with a cuff loosely implanted around the urethra andextending members implanted in a scrotum.

FIG. 7B is a schematic view of one embodiment of the incontinencetreatment device illustrated in FIG. 7A with the cuff tightened aroundthe urethra to provide the user with a continent state.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

Tissue includes soft tissue, which includes dermal tissue, sub-dermaltissue, ligaments, tendons, or membranes. As employed in thisspecification, the term “tissue” does not include bone.

In this specification the word “coapt” means to close or tosubstantially close. To coapt an opening is to bring two surfacestogether in close approximation such that the gap between the twosurfaces is reduced or eliminated. To coapt a urethra means tosubstantially yet reversibly close the urethra to impede the passage ofurine and provide a person with a continent state.

In this specification permanent means for as long as an incontinencetreatment device is implanted into a patient. Thus, an incontinencetreatment device having a permanent external portion outside of anabdominal wall of the patient provides the external portion outside ofthe patient for as long as the device is implanted in the patient.

In this specification a “user” is one into whom an incontinencetreatment device has been implanted.

In this specification “non-porous” means a material with nothrough-holes. For example, a non-porous material is characterized bythe absence of multiple holes that extend through the material from onesurface to the other surface. Non-porous, as employed in thisspecification, means a material that is configured to prevent tissuegrowth through the implanted material.

Embodiments provide an incontinence treatment device implantable into auser and including extending members that allow the user to selectivelymove from a state of continence (free from urine leakage) to a statethat allows urination. Tension applied to a first extending member isadapted to draw the junction toward the slot to tighten the cuff andcoapt the urethra to provide the user with a continent state. Tensionapplied to the second extending member is adapted to draw the junctureaway from the slot and loosen the cuff to relieve coaptation of theurethra and allow the user to urinate.

FIG. 1 is a top view of one embodiment of an incontinence treatmentdevice 20. The incontinence treatment device 20 (device 20) includes asupport 22 in the form of a sheet or a band that extends between a firstend 24 and a second end 26, with a first end portion 28 adjacent to thefirst end 24 and a second end portion 30 adjacent to the second end 26.An extending member 32 is attached to the support 22 at a junction 34that is located between the first end portion 28 and the second endportion 30. The support 22 is fabricated to be non-porous such thatafter implantation the non-porous support 22 discourages or preventstissue from growing onto or through the non-porous support 22.

One of the end portions 28, 30 is provided with a slot 36. For example,the first end portion 28 is provided with a slot 36 that is sized toreceive the second end portion 30. Inserting the second end portion 30through the slot 36, for example along a path 38, forms the support 22into a cuff (40 in FIG. 2) with the second end portion 30 extending in adifferent direction from the extending member 32.

Prior to assembly, the device 20 provides three segments or arms: afirst arm A1 that is provided by the first end portion 28 having theslot 36, a second arm A2 that is provided by the second end portion 30,and a third arm A3 that is provided by the second extending member 32.

In one embodiment, the second extending member 32 is attached at asubstantially orthogonal angle to the support 22. In one embodiment, thesecond extending member 32 is attached to the support 22 at an angleother than 90 degrees.

FIG. 2 is a perspective view and FIG. 3 is a top view of the support 22providing a cuff 40. The cuff 40 has two adjustment arms, a tighteningarm provided by the second end portion 30 and a loosening arm providedby extending member 32.

During implantation, the support 22 is placed on a first side of theurethra and the second end portion 30 is inserted through the slot 36 toform the cuff 40 around the urethra of a user. The assembled cuff 40thus has two extending members: a first extending member 42 provided bythe second end portion 30 and the second extending member 32 attached tothe support 22 between the first end portion 28 and the second endportion 30.

In one embodiment, the slot 36 is formed to have a slot width W (FIG.2). In one embodiment, the junction 34 between the member 32 and thesupport 22 includes a stopper 44 with a stop width S that is larger thanthe slot width W. The stop width S of the stopper 44 is configured toprevent the junction 34 from passing through the slot 36. In oneembodiment, the slot width W is sized to prevent passage of theextending member 32 through the slot 36.

In one embodiment, the support 22 has a height H extending betweenopposing sides of the support 22, and each of the first extending member42 and the second extending member 32 tapers from a first width L thatis substantially equal to the height H of the support 22 to a secondwidth D that is narrower than the height H of the support.

The support 22 is non-porous and is preferably fabricated from asynthetic material such as rubber, silicone, thermoplastic polymer,thermoset polymer, or blends of polymers or copolymers. One suitablematerial for fabricating the support 22 is silicone rubber. The support22 is fabricated to be non-porous to discourage tissue growth throughthe surface of the support 22.

In one embodiment, at least the cuff 40 portion of the device 20 iscoated with a substance that prevents tissue from attaching to orgrowing on a surface of the cuff 40. Tissue growth into or through thesupport 22 would undesirably fixate the support 22 into the patientafter it is implanted. The support 22 is fabricated from materials thatare non-porous and are selected to reduce or prevent the likelihood oftissue growth into or through the support 22. Although not bound to thistheory, tissue is expected to grow around the cuff 40 and envelop thecuff 40 in a pocket of tissue that allows the cuff 40 to move (tightenand loosen) relative to the urethra.

In one embodiment, since the non-porous support 22 is not a mesh. In oneembodiment, the non-porous support 22 has a thickness and is fabricatedfrom, for example, a solid film having substantially uniform densitythrough the thickness. Thus, in one embodiment, the support 22 and theresulting assembled cuff 40 are not inflatable.

FIG. 4A is a top view and FIG. 4B is an expanded view of the cuff 40.Tension T1 illustrates a pulling force applied to the first extendingmember 42. The tension T1 will draw the junction 34 up to the slot 36and reduce the diameter of the cuff 40, which is useful to coapt theurethra to provide the user with a continent state. With reference toFIG. 4B, the tension T1 applied to the first extending member 42tightens the cuff 40 until a stopper 44 is caught by the slot 36, whichprevents further collapse of the cuff 40.

The arc length of the support 22 extending from the junction 34 to theslot 36 (See FIG. 1) is selected such that the cuff 40 provides aninside diameter that is sufficient to collapse or coapt a human urethrawithout over compressing or eroding the urethra. The stopper 44 thusprovides a feature that prevents the cuff 40 from being collapsed tootightly against the urethra.

FIG. 4C is a top view illustrating a second tension T2 applied to thesecond extending member 32 to draw the stopper 44 away from the slot 36,which expands the cuff 40 to relieve coaptation of the urethra to allowthe user to urinate.

When implanted, the cuff 40 provides the user with the ability to pullon the first extending member 42 to achieve a continent state, and tosubsequently pull on the second extending member 32 to transition theuser into a state that allows urine to pass through the urethra.

In one embodiment, the cuff 40 is user-activated with each of the firstand second extending members 42, 32, respectively, implanted to beaccessible to the user such that user-applied tension T1 applied to thefirst extending member 42 will coapt the urethra to provide the userwith a continent state, and user-applied tension T2 applied to thesecond extending member 32 will relieve the coaptation of the urethraand allow the user to urinate.

FIG. 5 is a schematic view of one embodiment of the device 20 afterimplantation. The cuff 40 is implanted around the urethra U and theextending members 32, 42 are tunneled behind the pubic bone PB andproject through a wall of the abdomen. The extending members 32, 42 arelocated in a user-accessible location outside the body. Tension appliedby the user to the first extending member 42 tightens the cuff 40 tocoapt the urethra and provide the user with a continent state. Tensionapplied by the user to the second extending member 32 loosens the cuff40 to relieve the coaptation of the urethra and allow the user tourinate.

In one embodiment, the device 20 is implanted into the patient such thatthe cuff 40 surrounds the urethra U and the extending members 32, 42exit through the skin of the abdomen of the user. In one the suitableimplantation approach, a perineal incision (male) or a vaginal incision(female) is made, and tissue surrounding the urethra U is dissected togain access to the urethra U. A portion of the device 20 is insertedinto the incision. With reference to FIG. 1, the second end portion 30is subsequently maneuvered around the urethra U and inserted through theslot 36 in the first end portion 28 to form the cuff 40 around theurethra U. A suitable tunneling device, such as a pointed introducer 50or needle-like device, is inserted through the skin of the abdomen at anaccess point in an abdominal location that is superior to the pubicsymphysis PS. The introducer 50 is tunneled downward toward the urethraU and exits the incision formed in the patient. One of the extendingmembers 32, 42 is engaged with a T-slot 52 formed in an end portion 54of the introducer 50, and the introducer 50 is retracted upwards behindthe pubic bone PB and out of the access point formed in the abdominallocation. This maneuver is repeated on the contralateral side, in whichthe pointed introducer 50 is inserted through the skin and into theabdomen at a second access point that is superior to the pubic symphysisPS and again tunneled downward to exit the incision formed in thepatient. The other of the extending members 32, 42 is engaged with theslot 52 of the introducer 50, and the introducer 50 is retracted upwardsbehind the pubic bone PB and out of the second access point formed inthe abdomen.

The perineal or the vaginal incision is closed. The extending members32, 42 project outward from the abdomen through the access points formedin the abdominal locations. A suitable barrier is provided to preventthe transmission of bacteria into the abdominal locations. In otherapproaches, a prophylactic antibiotic is employed to reduce infection atthe abdominal locations.

The first and second extending members 42, 32, respectively, are thusaccessible to the user. Tension applied to the first extending member 42will tighten the cuff 40 to coapt the urethra U. Tension applied to thesecond extending member 32 will expand the cuff 40 to allow the user topass urine through the urethra U.

FIG. 6 is a schematic view of one embodiment of the cuff 40 implantedaround the urethra U with each of the extending members 32, 42 directedthrough one of the obturator foramina OF and out of the groin to auser-accessible location.

In one embodiment, the device 20 is implanted into the patient such thatthe cuff 40 surrounds the urethra U and the extending members 32, 42extend through an obturator foramen and out of the skin of the groin. Inone suitable implantation approach, a perineal incision (male) or avaginal incision (female) is made, and tissue surrounding urethra isdissected to gain access to the urethra U. With reference to FIG. 1, thesecond end portion 30 is maneuvered around the urethra U and insertedthrough the slot 36 in the first end portion 28 to form the cuff 40around the urethra U. The ends of the extending members 32, 42 aresuitably tunneled through each of the obturator foramen OF and out ofthe skin in the region of the groin.

In one embodiment, an introducer 60A is employed in an “inside out”approach to tunnel the ends of the extending members 32, 42 out of theskin of the groin. For example, an end of the second extending member 32is engaged with a tip 62 of the introducer 60A at a location outside ofthe incision (perineal for male or vaginal for female). The introducer60A is suitable curved to allow the end of the extending member 32 to bedirected behind the descending pubic ramus PR, through one of theobturator foramen OF, and out of the skin in the region of the groin. Asimilar maneuver is repeated on the contralateral side with a suitablyformed second introducer 60B to direct the end of the extending member42 through the other obturator foramen OF.

Another suitable approach directs an introducer through an “outside in”approach in which the introducer enters the skin in the groin region,penetrates the obturator foramen OF, and is directed around thedescending pubic ramus PR until a tip of the introducer exits theincision. The tip of the introducer is coupled with an end of one of theextending members 32, 42, and the introducer is retrieved back throughthe incision, the obturator foramen OF, and the skin in the groinregion. A similar maneuver is repeated on the contralateral side toplace the other of the extending members 32, 42.

Thus, as illustrated in FIG. 6, each of the first and second extendingmembers 42, 32, respectively, is implanted through one of the obturatorforamen and extends to the skin to a user-accessible location.

FIG. 7A is a schematic view of one embodiment of an open cuff 40implanted around the urethra U and FIG. 7B is a schematic view of thecuff 40 coapting the urethra U.

In one embodiment, the extending members 32, 42 are implanted in ascrotum of a male user, and although implanted internal to the user, areaccessible for selectively altering the user between a continent stateand a urination state.

Similar to the approaches described above, an incision is made, andtissue surrounding urethra is dissected to gain access to the urethra U.The non-porous sheet 22 is maneuvered around the urethra U to form thecuff 40 around the urethra U. The ends of the extending members 32, 42are directed into the scrotum Sc and the incision is closed.

The user pulls on the extending members 32, 42 through the skin of thescrotum to adjust the cuff 40 between the tightened and coapted stateand the loosened and open states. FIG. 7A illustrates the secondextending member 32 activated or pulled to open the cuff 40. In thisconfiguration, the user is provided with an opened cuff 40 that allowsthe user to pass urine through the urethra U.

FIG. 7B illustrates the first extending member 42 tensioned or otherwisepulled to collapse the cuff 40 around the urethra U, which provides theuser with a continent state.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of medical devices asdiscussed herein. Therefore, it is intended that this invention belimited only by the claims and the equivalents thereof.

1. An incontinence treatment device configured to be implanted in a bodyof a user, the incontinence treatment device comprising: a biocompatiblenon-porous support configured for implantation in the body of the userand having a first end portion provided with a slot and a second endportion, the second end portion is insertable through the slot to form acuff that is configured for placement around a urethra of the user; anda biocompatible extending member configured for implantation in the bodyof the user and attached to the support at a junction located betweenthe first end portion and the second end portion; wherein tensionapplied to the second end portion is adapted to draw the junction towardthe slot to tighten the cuff and thus provide the user with a continentstate; wherein tension applied to the extending member is adapted todraw the junction away from the slot and expand the cuff and thus allowthe user to urinate.
 2. The incontinence treatment device of claim 1,wherein the support has a height extending between a first side and asecond side of the support, and the second end portion and the extendingmember both taper from a first width that is substantially equal to theheight of the support to a second width that is narrower than the heightof the support.
 3. The incontinence treatment device of claim 1, whereinthe slot has a slot width and the second end portion has a stop widththat is larger than the slot width and is so configured to prevent thejunction from passing through the slot.
 4. The incontinence treatmentdevice of claim 1, wherein the support is not inflatable.
 5. Theincontinence treatment device of claim 1, wherein the support is not amesh.
 6. The incontinence treatment device of claim 1, wherein thesupport has a thickness and is fabricated from a film havingsubstantially uniform density through the thickness.
 7. The incontinencetreatment device of claim 1, wherein the cuff is user-activated witheach of the second end portion and the extending member being accessibleto the user such that user-applied tension applied to the second endportion is adapted to coapt the urethra and provide the user with acontinent state, and user-applied tension to the extending member isadapted to relieve coaptation of the urethra and allow the user tourinate.
 8. The incontinence treatment device of claim 1, wherein thenon-porous support has three arms including the first end portionprovided with the slot, the second end portion, and the extending memberthat is attached to the support at the junction.
 9. The incontinencetreatment device of claim 1, wherein the extending member is attached ata substantially orthogonal angle to the support.
 10. The incontinencetreatment device of claim 1, wherein the cuff is coated with a substancethat is configured to prevent tissue attachment to the cuff.
 11. Theincontinence treatment device of claim 1, wherein the non-porous supportincludes a first side spaced apart from a second side by a sheet width,and the first end portion has a width that is approximately equal to thesheet width and the second end portion tapers to a tapered width that isless than the sheet width.
 12. An incontinence treatment deviceconfigured to be implanted in a user, the incontinence treatment devicecomprising: a biocompatible non-porous sheet having a first side spacedapart from a second side by a sheet width, a first end portion having awidth that is approximately equal to the sheet width with a slot formedin the first end portion, and a second end portion that tapers to atapered width that is less than the sheet width; a biocompatibleextending member having a first end that is attached to the sheet at ajunction located between the first end portion and the second endportion, the extending member including a second end that has a widththat is less than the sheet width; wherein the tapered width of thesecond end portion of the sheet is insertable through the slot in thefirst end portion to form a cuff from the non-porous sheet that is sizedfor placement around a human urethra; wherein the slot has a slot widththat prevents the junction from passing through the slot.
 13. Theincontinence treatment device of claim 12, wherein the extending memberis attached at a substantially orthogonal angle to the sheet.
 14. Theincontinence treatment device of claim 1, wherein the non-porous supportcomprises a flexible material.
 15. The incontinence treatment device ofclaim 12, wherein the non-porous sheet comprises a flexible material.16. The incontinence treatment device of claim 1, wherein the second endportion of the non-porous support defines a substantially smooth outersurface that is configured to slide through the slot in the first endportion in at least two opposite directions.
 17. The incontinencetreatment device of claim 12, wherein the second end portion of thenon-porous sheet defines a substantially smooth outer surface that isconfigured to slide through the slot in the first end portion in twoopposite directions.
 18. The incontinence treatment device of claim 12configured such that the cuff is releasable restrained at a firstdiameter and upon application of sufficient tension to the extendingmember the cuff is released and expands in diameter.
 19. Theincontinence treatment device of claim 12 configured to permit expansionof the cuff upon application of sufficient tension to the extendingmember.
 20. The incontinence treatment device of claim 1 configured topermit expansion of the cuff upon application of sufficient tension tothe extending member.